510(k) Report

FDA applicant

Colorado Biomedical, Inc.

Evergreen, CO1 decision1988–19880 recalls

FDA records 1 decision for Colorado Biomedical, Inc. (Evergreen, CO) in 1988: 1 510(k) clearance. All are in product code JOS (Electrode, Electrosurgical). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Colorado Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Colorado Biomedical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Colorado Biomedical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Colorado Biomedical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JOSElectrode, Electrosurgical1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K881763Colorado Needle ElectrodeColorado Biomedical, Inc. · 19883cite it

What has FDA decided for it lately?

  • K881763Colorado Needle ElectrodeColorado Biomedical, Inc. · 1988

The one decision as Colorado Biomedical, Inc. →

Other applicant names beginning “Colorado”

FDA records each applicant name separately; these may or may not be the same firm.

Colorado Medical, Inc. 6Colorado Medtech, Inc. 2Colorado Therapeutics, LLC 2Colorado Catheter Company, Inc. 1Colorado Hearing Systems, Inc. 1